Medical Device Regulation

Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices.

Cover image
Title page
Table of Contents
Copyright
Dedication
Biography
Endorsements
Foreword
Acknowledgments
Section 1. How to study and market a medical device
Chapter 1. Overview of medical device regulation
Introduction
A history of medical device regulation and oversight in the United States
Chronological milestones in the history of medical device legislation
FDA guidance documents
Chapter 2. How to market a medical device
Introduction
Medical device risk-based classification system
A step-by-step process for FDA approval/clearance to market a medical device
510(k) exempt 21 CFR 862–892
510(k) submission 21 CFR Part 807 Subpart E
Additional Information (AI) request
Medical device accessories
Case study—regulatory pathways for medical devices
Chapter 3. Premarket notification [510(k)]
Introduction
What is a premarket notification [510(k)]?
Evaluating substantial equivalence in premarket notifications [510(k)]
Example of substantial equivalence table
Recommendations for 510(k) submission
Who is required to submit a 510(k)?
When a 510(k) is required
The 510(k) decision-making process
Predicate device
Guide to building a successful 510(k) submission
Tips on how to prepare a successful FDA 510(k) submission
How to pass the FDA refusal to accept (RTA) screening process
Most common reasons for FDA refusal of 510k submissions
FDA actions on premarket notification (510(k)) submissions: effect on FDA review clock and goals
FDA actions
Substantive interaction
Request for additional information
Issue an order declaring a device SE
Issue an order declaring a device NSE
Not-a-device decision
510(k) third party review program
Scientific integrity of the 510(k) process
Strengths, weaknesses, and flexibilities of the 510(k) process
Premarket notification [510(k)] versus premarket approval (PMA)
Conclusion
Chapter 4. Device modifications requiring new 510(k) submission
Introduction
Guidance documents history
Deciding when to submit a 510(k) for a change to an existing device
The 510(k) process and the quality system regulation
510(k) guiding principles
Labeling changes
Technology, engineering, and performance changes
Materials changes
Risk-based assessment of changes
Software-specific changes
Technology, engineering, performance, and materials changes for in vitro diagnostic devices
Is the change identified in device-specific final guidance or classification regulation?
Does a risk-based assessment of the changed device identify any new risks or significantly modified existing risks?
Do design verification and/or validation activities produce any unexpected issues of safety or effectiveness?
Conclusion
Chapter 5. Premarket approval (PMA)
PMA historical background
Overview
When a PMA is required
Substantive review: in-depth scientific, regulatory, and quality system review
Panel review: review and recommendation by the appropriate advisory committee
Standard conditions of approval
Summary of safety and effectiveness data
Successful PMA application requires early collaboration and day-100 meetings
PMA review checklist
FDA action on a PMA
PMA application methods
PMA postapproval requirements
FDA guidance on postapproval studies
Postapproval (annual) reports
PMA supplement
When to submit a PMA supplement
Changes without a PMA supplement
Types of PMA supplements
PMA manufacturing site change supplement
Annual (periodic) report or 30-day supplements
Document to file
New PMA
PMA amendments
Withdrawal and resubmission
PMA import and export
Conclusion
Chapter 6. Investigational device exemption
Overview
IDE definitions and acronyms
Understanding FDA regulatory requirements for an IDE for sponsor-investigators
Regulatory scope of IDE
Who must apply for an IDE?
Determining when an IDE is needed
Filling an investigational device exemption application
Submitting an IDE
Following the receipt of the IDE by the FDA
Responding to the FDA
Registration with Clinicaltrials.gov
Regulatory requirements for an IDE during the study and at completion
Reporting responsibilities for sponsor-investigators
Monitoring responsibilities for sponsor-investigators
Safety reports
IDE withdrawal, termination, and final report
IDE Institutional Review Boards
IRB responsibilities
IDE informed consent
IDE financial disclosure
IDE supplements for new facilities(s)
Acceptance of data from clinical trials conducted outside the United States to support an IDE
Key takeaways from acceptance of data from clinical trials conducted outside the United States to support an IDE
Humanitarian devices
Prohibition on profit
HDE application process
Institutional review board approval role
Key takeaways of HDE
FDA requirements for import and export of investigational devices
Summary and conclusion
Chapter 7. In vitro diagnostics
Introduction
Understanding IVD testing
Challenges with IVD testing
FDA regulatory oversight
Investigational Studies for IVDs
Radio frequency identification application in IVD
IVD labeling
Types of IVD tests
What can happen when patients are exposed to bad IVD tests?
Inova Genomics Laboratory (Inova) genetic tests
Limitations of direct-to-consumer tests
Drugs of abuse tests
Home-use tests
Laboratory developed tests
Emergency use authorizations
Precision medicine
Bioresearch monitoring inspections
COVID-19 impact on in vitro diagnostics
Summary and conclusion
Chapter 8. Clinical studies for medical device
Introduction
Clinical trial development and design
522 postmarket surveillance studies program
Use of modeling and engineering tests to reduce clinical trial requirements
Use of evidence from clinical experience
Clinical trial regulatory requirements
The Regulatory basis for medical device clinical studies
Good clinical practice (GCP)
Clinical data to support FDA submissions
Clinical trial data versus performance testing data
The investigational plan or protocol
Clinical outcome studies
Blinding (masking)
Meta-analysis
Literature summary
Sustaining the quality of clinical studies
Valid scientific evidence
Bioresearch monitoring
Responsibilities of sponsors, investigators, and IRBs
Responsibility for registration on ClinicalTrials.gov
Foreign (international) clinical investigators and clinical trials
Technology used in enabled clinical trials
Technology used to modernize clinical trials
Analytical software solutions in clinical trials
Future of technology used to modernize clinical trials
Future challenges and opportunities of clinical trial
Chapter 9. Medical device labeling requirements
Introduction
Statutory bases for labeling requirements
Tips on how to comply with medical device labeling requirements
FDA labeling approval
Use of symbols in medical device labeling
Prescription device labeling requirements
Labeling requirements: misbranding
Advertising and promotion
Area separation and inspection of medical device labeling
Label check and record
Labeling changes
Control number
Sterile device labeling
Shelf-life labeling requirements
Latex labeling requirements for medical devices
Instructions for use (IFU) labeling consideration
Unique device identifier (UDI)
Global Unique Device Identification Database
Direct marking
Unique Device Identification for convenience kits
The advent of RFID in medical devices
The importance of RFID?
The benefit of RFID
Conclusion
Chapter 10. FDA Medical Devices Advisory Committees
Overview
Medical Devices Advisory Committee
Advisory committee structure
What is an FDA advisory committee?
When does an FDA advisory committee convene?
Advisory committee meeting
Advisory committee members
Example of FDA advisory committee full day agenda
Evaluating appearance issues and granting authorizations for participation in FDA advisory committees
Examples of appearance issues and factors the FDA would consider in determining whether to grant a Section 502 authorization
Public availability of advisory committee members' financial interest information and waivers
Procedures for meetings of the Medical Devices Advisory Committee
Panel expertise
Preparation for panel meetings
Premarket submission meetings
Regulatory issues meetings
Conduct of panel meetings
Chapter 11. Human factors and medical devices
Introduction
Overview of human factors engineering process
Conclusion and summary
Outlook and future developments
Chapter 12. Mobile medical applications, software, and wireless coexistence
Introduction
FDA regulatory oversight
What are mobile medical apps?
Medical Device Data Systems
Regulatory approach for mobile medical apps
Mobile apps for which FDA intends to exercise enforcement discretion
Software as a Medical Device
FDA Issues a Draft Guidance for Content of Premarket Submissions for Device Software Functions
Wireless coexistence and wireless medical devices
Summary and conclusion
Chapter 13. Cybersecurity in medical devices
Overview
Why cybersecurity
The FDA's work in cybersecurity
FDA guidance document on cybersecurity
Applicable definitions
FDA guidance on managing cybersecurity in medical devices
Managing cybersecurity risks according to ISO 14971
Applying security standards from IEC 62304 to full medical device software lifecycle
Labeling guidelines for devices with cybersecurity risks
Cybersecurity documentation for premarket submission
General approach to medical device cybersecurity
Summary recommendations for medical device cybersecurity
Conclusion
Section 2. Postmarket activities and FDA collaboration
Chapter 14. Postmarket surveillance and requirements
Overview
Postmarket surveillance requirements—FDA 21 CFR Part 822
Medical device risks to patient
Sources of postmarket data
Medical device reporting (MDR)
Medical device recalls, corrections and removals
Reporting to the FDA under part 806
Medical Device Tracking
Examples of medical device recalls
Summary and conclusion
Chapter 15. Compliance and enforcement
Overview
FDA form 483 inspectional observations
QS inspections
Level 1 inspections—PAC 82845A
Level 2 inspections—PAC 82845B or 82845P
Level 3 inspections—PAC 82845C
For cause inspections—PAC 82845G
Risk-based work plan inspections—PAC 82845H
Foreign inspections
Advisory actions
Office of criminal investigations
Medical device exports and imports
Importing into the USA
Import for export overview
Conclusion and summary
Chapter 16. The quality system regulation
Introduction
Scope of the QSR
Applicability of the quality system regulation
The seven (7) subsystems of QSR
Difference between the FDA QSR and ISO 13485
Medical Device Single Audit Program and ISO 13485:2016
Conclusion
Quality system regulations (21 CFR Part 820) case study
Discussion
Chapter 17. Risk management
Introduction
FDA interpretation of benefit-risk in medical device
ISO 14971
Medical device safety and risk management
FDA relationship with ISO 14971: medical device—application of risk management to medical devices
Why should we perform risk management?
Risk management process
Risk management plan
Risk management file
Risk analysis process
Risk evaluation
Risk control
Residual risk evaluation
Benefit and risk analysis
Evaluation of overall residual risk acceptability
Risk management report
Production and post-production information
Barriers to optimizing risk management for medical devices
Foundation for risk assessment and risk management
Factors to consider when making benefit-risk determinations
Case studies of benefit-risk determinations
Summary and conclusion
Chapter 18. Meeting and collaboration with the FDA
Introduction
Sponsor meetings with the FDA
Formal meetings
Food and Drug Administration Modernization Act of 1997
Determination meeting
Agreement meeting
Strategies to prepare for meetings with the FDA
Chapter 19. Future of the medical device industry
Emerging technology trends and the digital revolution
Emerging assessment tools
Diagnostics and point-of-care platform
Artificial intelligence and machine learning in software as a medical device
Background of AI/ML-based software as a medical device
Types of AI/ML-based SaMD modifications
A total product lifecycle (TPLC) regulatory approach for AI/ML-based SaM
Quality systems and good machine learning practices (GMLP)
Initial premarket assurance of safety and effectiveness
Transparency and real-world performance monitoring of AI/ML-based SaMD
Staying ahead of the future
Summary
Appendix. FDA guidance documents (medical devices)
Regulatory affairs professionals society (RAPS)
Quality management system manual
Glossary
Index

Life Sciences

Physical Sciences & Engineering

Social Sciences & Humanities

Health

Medical Device Regulation

FDA-CDRH Manufacturing, Policies and Regulation Handbook

Purchase options

World Book Day Celebration!

Institutional subscription on ScienceDirect

Elijah Wreh

Related books